Cleared Traditional

K831387 - HS-100 HEADSPACE SAMPLING ACCESSORY
(FDA 510(k) Clearance)

K831387 · The Perkin-Elmer Corp. · Toxicology

Aug 1983

Decision

118d

Days

Class 1

Risk

K831387 is an FDA 510(k) clearance for the HS-100 HEADSPACE SAMPLING ACCESSORY, a Chromatography(gas), Clinical Use (Class I — General Controls, product code KZQ), submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1983, 118 days after receiving the submission on April 28, 1983. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2250.

Submission Details

510(k) Number	K831387 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1983
Decision Date	August 24, 1983
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—